Improving health is our policy
Effective not later than April 1, 2012 (and annually thereafter), requires prescription drug manufacturers and authorized distributors of record (ADR) to report to the Secretary of HHS on information pertaining to the distribution of drug samples and the requesting practitioner, as well as other information determined appropriate by HHS.
Prior to January 2013, in the spring of 2012, FDA issued a draft compliance policy for public comment, in which the FDA stated that it did not intend to object until at least October 1, 2012, if manufacturers and ADRs did not submit information under section 6004. FDA expects to issue further guidance regarding the compliance policy sometime “in 2013” per the FDA’s webpage (which contains supporting documents) on this provision. In the meantime, the FDA is encouraging manufacturers and ADRs who have not done so to submit their 2011 and 2012 data.
On July 10, the FDA announced the availability of draft guidance for the industry titled, “Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act” The guidance here provides information to assist persons submitting drug sample information under ACA section 6004, which required submission of certain drug sample information to FDA by April 1 of each year beginning in 2012. The draft guidance revises the draft compliance policy guide issued on April 3, 2012. Comments on the underlying proposed information collection are due by September 9, 2014. Comments pertaining to the draft guidance itself may be submitted at any time, though in order to inform the final product, are requested by October 9, 2014.
SEC. 6004. PRESCRIPTION DRUG SAMPLE TRANSPARENCY. Part A of title XI of the Social Security Act (42 U.S.C. 1301 et seq.), as amended by section 6002, is amended by inserting after section 1128G the following new section: ‘‘SEC. 1128H ø42 U.S.C. 1320a–7i¿. REPORTING OF INFORMATION RELATING TO DRUG SAMPLES. ‘‘(a) IN GENERAL.—Not later than April 1 of each year (beginning with 2012), each manufacturer and authorized distributor of record of an applicable drug shall submit to the Secretary (in a form and manner specified by the Secretary) the following information with respect to the preceding year: ‘‘(1) In the case of a manufacturer or authorized distributor of record which makes distributions by mail or common carrier under subsection (d)(2) of section 503 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353), the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by— ‘‘(A) the name, address, professional designation, and signature of the practitioner making the request under subparagraph (A)(i) of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and ‘‘(B) any other category of information determined appropriate by the Secretary. ‘‘(2) In the case of a manufacturer or authorized distributor of record which makes distributions by means other than mail or common carrier under subsection (d)(3) of such section 503, the identity and quantity of drug samples requested and the identity and quantity of drug samples distributed under such subsection during that year, aggregated by— ‘‘(A) the name, address, professional designation, and signature of the practitioner making the request under subparagraph (A)(i) of such subsection, or of any individual who makes or signs for the request on behalf of the practitioner; and ‘‘(B) any other category of information determined appropriate by the Secretary. ‘‘(b) DEFINITIONS.—In this section: ‘‘(1) APPLICABLE DRUG.—The term ‘applicable drug’ means a drug— ‘‘(A) which is subject to subsection (b) of such section 503; and ‘‘(B) for which payment is available under title XVIII or a State plan under title XIX or XXI (or a waiver of such a plan). ‘‘(2) AUTHORIZED DISTRIBUTOR OF RECORD.—The term ‘authorized distributor of record’ has the meaning given that term in subsection (e)(3)(A) of such section. ‘‘(3) MANUFACTURER.—The term ‘manufacturer’ has the meaning given that term for purposes of subsection (d) of such section.’’.
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